A Randomised, Double-blinded, Placebo-controlled, Parallel Study, to Assess the Effect of a Probiotic on the Incidence, Duration and Severity of Upper Respiratory Tract Infections in Healthy Children

The Archer-Daniels-Midland Company1 site in 1 country200 target enrollmentJanuary 30, 2023

ConditionsUpper Respiratory Tract Infections Upper Resp Tract Infection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Upper Respiratory Tract Infections
Sponsor: The Archer-Daniels-Midland Company
Enrollment: 200
Locations: 1
Primary Endpoint: Effect of 26 week consumption of probiotic on the total number of days that, otherwise healthy, children suffer from upper respiratory tract infection (URTI)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study evaluates the efficacy of a single strain probiotic on the incidence, duration and severity of upper respiratory tract infections in healthy, school-age children.

Registry

clinicaltrials.gov

Start Date

January 30, 2023

End Date

March 13, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The Archer-Daniels-Midland Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have a parent/guardian able to give written informed consent.
•If ≥7 years, be able to give written informed assent.
•Healthy children aged 2 - 8 years old.
•In general good health, as determined by the investigator.
•Attending a registered childcare provider or school.
•Willing to consume the study product daily for the duration of the study.

Exclusion Criteria

•Has URTI symptoms at the time of randomisation.
•Are \<2 or ≥9 years old.
•Diagnosed with concomitant chronic infections, chronic systemic diseases, autoimmune diseases (e.g. asthma - generally only formally diagnosed after child is 6 years), immunodeficiency, metabolic diseases, chronic respiratory tract diseases including respiratory allergies and cystic fibrosis or congenital cardiac defects.
•Has a family household member that smokes cigarettes in the home.
•Has taken antibiotics within the previous 2 weeks prior to randomisation.
•Has taken probiotic supplements within the previous 2 weeks prior to randomisation
•Daily intake of immune stimulating products, including but not limited to echinacea, vitamin C and zinc in the 2 weeks before randomisation (multivitamins allowed).
•Has any significant health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results.
•Taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results.
•Has an active gastrointestinal disorder or previous gastrointestinal surgery (appendicectomy allowed).

Outcomes

Primary Outcomes

Effect of 26 week consumption of probiotic on the total number of days that, otherwise healthy, children suffer from upper respiratory tract infection (URTI)

Time Frame: Entire follow up period (total of 180 days)

Presence of an URTI defined by a score of \>2 on the Jackson Cold Scale (maximum score 3) where a lower score means better outcomes compared to baseline

Secondary Outcomes

Effect of 26 week consumption of probiotic on Salivary Immunoglobulin A levels (IgA) (mg/dL)(Day 0, Day 180)
Effect of 26 week consumption of probiotic on the incidence of gastrointestinal infections(Day 0, Day 90, Day 180)
Effect of 26 week consumption of probiotic on the average duration of URTIs reported by participants(Day 0, Day 90, Day 180)
Effect of 26 week consumption of probiotic on the total number of reported missed days of school/childcare due to illness(Day 0, Day 90, Day 180)
Effect of 26 week consumption of probiotic on the reported incidence of antibiotic use(Day 0, Day 90, Day 180)
Effect of 26 week consumption of probiotic on the number of children reporting at least one URTI(Day 0, Day 90, Day 180)
Effect of 26 week consumption of probiotic on the severity of URTI-related symptoms reported by participants(Day 0, Day 90, Day 180)